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Terminated

Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon Catalog # 4545

FDA Recall Z-0552-03 · Posted 2003-02-08

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Date Initiated2003-01-29
Date Terminated2004-03-10
Product Quantity255 units

Reason for Recall

Breach in sterile barrrier may compromise sterility

Firm Action

Boston Scientific/Microvasive, Natick, MA initiated a voluntary recall by letter dated 1/27/03, and mailed 1/29/03. Accounts were requested to remove affected lots and return product to Boston Scientific. A verification form was provided to monitor effectiveness of the recall notification. Non-reponders will be recontacted.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970052EXTRACTORRXBoston Scientific Corp · 1997-03-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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